InfluenzaPhase 4NCT01306253

A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2009/2010 Influenza Virus Strains for the Northern Hemisphere

A Phase 4 study testing Inflexal V in people with Influenza, run by Crucell Holland BV at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Inflexal V
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 114 participants
Where: 1 siteSwitzerland
Study dates: Jun 2009to Jun 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy female and male adults
Aged ≥18 to ≤60 years or >60 years on Day 1
Written informed consent

Who cannot join

Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
Acute febrile illness (≥38.0 °C)
Prior vaccination with an influenza vaccine in the past 330 days
Known hypersensitivity to any vaccine component
Previous history of a serious adverse reaction to influenza vaccine
History of egg protein allergy or severe atopy

Show all 15Show fewer

Known blood coagulation disorder
Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)
Investigational medicinal product received in the past 3 months (90 days)
Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
Pregnancy or lactation
Participation in another clinical trial
Employee at the investigational site, or relative or spouse of the investigator
Suspected non-compliance

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Covance Clinical Research Unit AG
Allschwil, 4123

Other trials in Switzerland

About this study

Official title: Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2009/2010-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) Regulations

This study is to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines.

Conditions: Influenza
Being tested: Inflexal V
Keywords: Influenza, Virus, Vaccination, Immunisation
Medical subject headings: Influenza, Human, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inflexal VBiological
Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose:
- 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus
- 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
- 15 µg HA antigen of B/Brisbane/60/2008-like virus
Dose: intramuscular administration (M. deltoides) of a single dose of 0.5 mL on Day 1

Study groups in NCT01306253
Study group	Role	What they receive
Elderly	Experimental	Elderly subjects aged over 60 years Receives: Biological: Inflexal V
Adults	Experimental	Adults from 18 to 60 years old inclusive Receives: Biological: Inflexal V

What is being measured

The primary outcome is the main question the study is designed to answer.

Seroconversion
Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40
Measured: Day 22 ± 2 days
Seroprotection
Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40
Measured: Day 22 ± 2 days
Fold Increase in Geometric Mean Titer (GMT)
GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value
Measured: Day 22/Day 1

Secondary outcomes (2)

Safety: Numbers of Subjects Reporting Solicited Local Adverse Events
Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination
Measured: Days 1 to 4 inclusive, and Day 22
Numbers of Subjects Reporting Solicited Systemic Adverse Events
Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination
Measured: Days 1 to 4 inclusive, and Day 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Jun 2009

First posted1 Mar 2011 (estimated)
Study startJun 2009
Primary completionJun 2009
Study completionJun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01306253
Sponsor's protocol ID: INF-V-A003
Status last verified: Aug 2013
First submitted: 28 Feb 2011
Last updated: 9 Sep 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2009/2010-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) Regulations
ClinicalTrials.gov ID: NCT01306253
Acronym / sponsor ID: INF-V-A003
Conditions: Influenza
Keywords: Influenza, Virus, Vaccination, Immunisation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: Crucell Holland BVIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 1 Mar 2011 (estimated)
Results: Posted 20 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Elderly	Experimental	Biological: Inflexal VElderly subjects aged over 60 years
Adults	Experimental	Biological: Inflexal VAdults from 18 to 60 years old inclusive

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Healthy female and male adults
Aged ≥18 to ≤60 years or >60 years on Day 1
Written informed consent

Key exclusion criteria (15 listed)

Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
Acute febrile illness (≥38.0 °C)
Prior vaccination with an influenza vaccine in the past 330 days
Known hypersensitivity to any vaccine component
Previous history of a serious adverse reaction to influenza vaccine

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Inflexal VInflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose: * 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus * 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus * 15 µg HA antigen of B/Brisbane/60/2008-like virus Dose: intramuscular administration (M. deltoides) of a single dose of 0.5 mL on Day 1	Biological	Adults, Elderly

Primary outcome

Seroconversion
Time frame: Day 22 ± 2 days
Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40
Seroprotection
Time frame: Day 22 ± 2 days
Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40
Fold Increase in Geometric Mean Titer (GMT)
Time frame: Day 22/Day 1
GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value

2 secondary outcomes

Safety: Numbers of Subjects Reporting Solicited Local Adverse Events
Time frame: Days 1 to 4 inclusive, and Day 22
Numbers of Subjects Reporting Solicited Systemic Adverse Events
Time frame: Days 1 to 4 inclusive, and Day 22

Results and safety

Results posted to the registry on 20 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adults	57	56
Elderly	57	56

Primary outcome: Seroconversion

Time frame: Day 22 ± 2 days. Number. Unit: Number of subjects

Measure	Adults n = 56	Elderly n = 56
A/Brisbane/59/2007	29	32
A/Brisbane/10/2007	37	35
B/Brisbane/60/2008	34	33

Population analysed: Intention-to-treat (ITT) and According-to-protocol (ATP) populations excludes one subject per group lost to follow up

Primary outcome: Seroprotection

Time frame: Day 22 ± 2 days. Number. Unit: Number of subjects

Measure	Adults n = 56	Elderly n = 56
A/Brisbane/59/2007	47	47
A/Brisbane/10/2007	49	51
B/Brisbane/60/2008	51	46

Population analysed: ITT/ATP

Primary outcome: Fold Increase in Geometric Mean Titer (GMT)

Time frame: Day 22/Day 1. Number. Unit: Fold (ratio)

Measure	Adults n = 56	Elderly n = 56
A/Brisbane/59/2007	9.60	5.93
A/Brisbane/10/2007	9.25	8.30
B/Brisbane/60/2008	7.91	6.93

Population analysed: ITT/ATP

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adults	0 of 57 (0%)	29 of 57 (50.9%)	Not reported
Elderly	0 of 57 (0%)	16 of 57 (28.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Seiberling, MD principal investigator

Covance Clinical Research Unit AG

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Inflexal V in people with Influenza, run by Crucell Holland BV at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion (time frame: Day 22 ± 2 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01306253.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2013.